Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01578824
First received: November 9, 2011
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.

Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in a prospective study evaluating patients with vitamin D resistant rickets and in healthy controls.

Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as assessed by methacholine challenge test.

Secondary outcome parameters: All other parameters are the secondary end points.


Condition Intervention
Asthma
Vitamin D Resistant Rickets
Other: Methacholine Challenge Test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Metacholine Challenge Test [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: Yes ]
    As assessed by methacholine challenge test with determination of PC20.


Secondary Outcome Measures:
  • IgE [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    in peripheral Blood count

  • CBC [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    in peripheral Blood count

  • Fractional Exhaled NO [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    determination of exhaled NO in Exhaled breath

  • skin tests for inhaled allergens [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
  • Inhaled breath condensate [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
  • C reactive protein [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    in peripheral Blood count

  • 25 OH vitamin D3 [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    in peripheral Blood count


Enrollment: 26
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Control Other: Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Other Name: Airway Hyperresponsiveness test
Active Comparator: Vitamin D resistant Rickets
Vitamin D resistant Rickets patients
Other: Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Other Name: Airway Hyperresponsiveness test

Detailed Description:

Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets.

Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions. Vitamin D resistant rickets patients lack vitamin D receptors and cannot absorb vitamin D.

Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate.

Design: Prospective study evaluating these parameters in patients with vitamin D resistant rickets and in healthy controls.

Participant selection: The study group will consist of vitamin D resistant rickets patients followed and treated at the Pediatric Endocrinology Department at our hospital. The study group will be compared to an age- and sex-matched healthy control group that had a negative methacholine challenge test.

Sample size: 40 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, pulmonary function tests, methacholine challenge test with determination of PC20, exhaled nitric oxide (eNO), and exhaled breath condensate (EBC). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, and Vitamin D levels. Prick skin test for inhaled allergens will be performed. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits.

Primary end point: Airway reactivity as assessed by methacholine challenge test.

Secondary outcome parameters: All other parameters are the secondary end points.

  Eligibility

Ages Eligible for Study:   3 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Vitamin D Resistent Rickets
  • Age between 3 - 40 years

Exclusion Criteria:

  • Any Chronic Lung Disease
  • Febrile Illness in last 2 weeks
  • Inhaled Corticosteroids over the past 2 weeks
  • Bronchodilators over the past 24 hours
  • Participation in any other clinical studies over the past 4 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578824

Locations
Israel
RAMBAM Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Lea Bentur, Prof. Rambam MC
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01578824     History of Changes
Other Study ID Numbers: Vit D and asthma in VDRR CTIL
Study First Received: November 9, 2011
Last Updated: June 12, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Rickets
Vitamin D
airway hyperreactivity
Exhaled breath condensate

Additional relevant MeSH terms:
Asthma
Rickets
Familial Hypophosphatemic Rickets
Rickets, Hypophosphatemic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hypophosphatemia

ClinicalTrials.gov processed this record on August 21, 2014